Product Design Control - Limerick

The MSc in Product Design Control (Medical Device) is a specialised, industry-aligned postgraduate programme that prepares professionals to lead and contribute effectively to regulated product development environments. Product Design Controls are a structured framework which transforms innovation and technology into safe, effective, and compliant products. They ensure that regulated industries design the right product and consistently make it correctly every time. The programme strongly focuses on EU MDR, FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62366-1. This programme develops core competencies across the entire product lifecycle from early concept to design transfer and post-market surveillance.



Learners will build proficiency in regulatory and quality requirements, risk management, usability engineering, and structured project management. Through intensive coursework, collaborative case studies, and an applied research dissertation, graduates will emerge capable of designing, verifying, validating, and transferring safe and effective products that meet user needs, intended use, and regulatory expectations. The programme is designed for engineers, scientists, regulatory professionals, and quality leaders aiming to transition into or advance within medical device and other regulated industries (including food, pharmaceuticals, aerospace, automotive, and high-tech manufacturing).



There will be 14 hours of contact time running across 3 days per week.

Semester 1

Product Design Control Credits: 10

Quality Management Credits: 10

Project Management Credits: 10

Dissertation (Year-Long Module) Credits: 30



Semester 2

Process Design Standards and Regulatory Affairs Credits: 10

Design Verification and Validation Credits: 10

Product Risk Management Credits: 10

Dissertation (Year-Long Module) Credits: 30

A minimum honours bachelor degree (Level 8) in any discipline.



Or



A minimum ordinary bachelor degree (Level 7) in any discipline with minimum two years relevant work-based experience and/or ability, evidenced by an RPL portfolio of prior experience and learning



Or



Equivalent Qualifications. Applicants with equivalent qualifications on the European and International frameworks will also be considered. International students must evidence a proficiency in English language for example IELTS 6.0

1 year, full-time.

Career Opportunities

This programme will enhance a learner’s career in manufacturing, R&D and regulated companies by developing increasing levels of competence, professionalism, critical thinking, problem-solving and decision-making necessary to work in the regulated industry. This equips graduates to work in regulatory affairs, quality or/and engineering and science environments. There are multiple roles a graduate from the programme can seek in areas such as: Product Design Control, Design Control, Product Risk Management, R&D Engineer, Design Assurance Engineer, Product Manager, Regulatory Engineer, Validation Engineer, Quality Engineers, Quality Control, Quality Management, Regulatory affairs Management, Project Engineer, Product Management and Process Engineer.



Further Study

Upon successful completion of this programme, graduates have the opportunity to complete Level 9/10 programmes here at TUS or elsewhere.